Good Clinical Practice. This study will be conducted in accordance with the International Conference on Harmonization (ICH) for Good Clinical Practice (GCP) and the appropriate regulatory requirements. The Investigator will be thoroughly familiar with the appropriate use of the study medication as described in the protocol and the Investigator’s Brochure. Essential clinical documents will be maintained to demonstrate the validity of the study and the integrity of the data collected. The Investigator/institution should establish master files at the beginning of the study which will be maintained and updated during the study and retained thereafter according to the appropriate regulations.
Good Clinical Practice. 3.1.2 The Guidelines;
Good Clinical Practice or GCP shall mean any and all laws, rules, regulations, guidelines and generally accepted standards and requirements regarding the ethical conduct of clinical trials, including without limitation the U.S. Code of Federal Regulations (CFR) Title 21, ICH GCP Guidelines E6(R1), current step 4 version, dated 10 June 1996, as amended from time to time, national legislation implementing European Community Directive 2001/20/EC of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, European Community Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards to investigational medicinal products for human use. Execution Version
Good Clinical Practice. The current study will be conducted in compliance with the protocol, International Conference on Harmonization Good Clinical Practice (ICH-GCP), and the applicable regulatory requirements. Study personnel involved in conducting this study will be qualified by education, training, and experience to perform their respective task(s) in accordance with GCP.
Good Clinical Practice. The procedures set out in this study protocol pertaining to the conduct, evaluation, and documentation of this study are designed to ensure that NovImmune, its authorised representative, and Investigator abide by Good Clinical Practice (GCP), as described in International Conference on Harmonization (ICH) Guideline E6 and in accordance with the general ethical principles outlined in the Declaration of Helsinki. The study will receive approval from an Independent Ethics Committee (IEC) prior to commencement and where applicable by law also from National Competent Authorities. The Investigator will conduct all aspects of this study in accordance with applicable national, state, and local laws of the pertinent regulatory authorities.
Good Clinical Practice. The study will be conducted according to the study protocol and to the principles of good clinical practice ISO14155:2011.
Good Clinical Practice. Section 7.1 Due to the time commitment and resources needed to manage site visits, many Institutions require that the language in the Agreement identify specific timeframes as to when those site visits may occur (e.g., identifying the time interval between visits or the expectation regarding the length of the visit). To provide more amenable language for Sponsors, this Section simply requires that visits be scheduled in advance to occur at mutually agreeable times during normal business hours. Institutions will also occasionally incorporate costs for time and effort associated with not-for-cause audits.
Good Clinical Practice. A standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials, that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity and confidentiality of subjects are protected. In the U.S., the standards are set forth in the United States Code of Federal Regulations (“CFR”).
Good Clinical Practice. Since January 1, 2012, all clinical trials conducted by, or to the Company’s knowledge, on behalf of, any Group Company have been and are being conducted in material compliance with requirements of good clinical practice (as set forth by the FDA in Title 21 of the CFR, Part 56, 312, 314, 600 and 812 and/or any foreign equivalents thereof) (“Good Clinical Practices”) to the extent such clinical trials were or are required to be in compliance with Good Clinical Practice under applicable Law. Since January 1, 2012, all human clinical trials conducted by or, to the Company’s knowledge, on behalf of the any Group Company have been, and are being, conducted in material compliance with the applicable requirements of Good Clinical Practice, Informed Consent, and all applicable requirements relating to protection of human subjects contained in Title 21 of the CFR, Parts 50, 54, 56 and 58, to the extent such human clinical trials were or are required to be in compliance with the applicable requirements of Good Clinical Practice, Informed Consent, and all applicable requirements relating to protection of human subjects contained in Title 21 of the CFR, Parts 50, 54, 56 and 58 under applicable Law.
Good Clinical Practice. “Good Clinical Practice” shall have the meaning set forth in the FDCA.
